BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIKE PUSHER

    MDR report key: 4375356 · Received December 23, 2014

    Report

    Report Number
    MW5039841
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    December 15, 2014
    Report Date
    December 23, 2014
    Manufacturer
    SYNTHES
    Product Code
    HXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT INSERTION OF A TROCHANTERIC FIXATION NAIL FOR FRACTURED HIP. BALL SPIKE PUSHERS WERE USED TO HELP REDUCE THE FRACTURE. UPON REMOVAL OF THE SPIKE PUSHER, THE CLIP DISLODGED IN THE PATIENT'S FASCIA. FINAL FLUOROSCOPY DONE IN THE OPERATING ROOM WAS NEGATIVE FOR RETAINED CLIP PER PHYSICIAN. ROUTINE POST OPERATIVE FILMS OF THE HIP OBTAINED IN PACU SHOWED THE CLIP FROM THE BALL SPIKER PUSHER WAS RETAINED. REMOVAL OF CLIP WAS DONE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848403 SPIKE PUSHER SPIKE PUSHER HXO SYNTHES 390.71

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention